Monday, December 22, 2014

I am all for regulating the marketing of electronic cigarettes so that it does not target youth. However, I submit that measures to accomplish this should represent legitimate (i.e., constitutionally valid) government actions.

Last Friday, Senator Dick Durbin (D-IL) and Representatives Henry Waxman (D-CA) and Frank Pallone (D-NJ) sent a letter to all the state Attorneys General requesting that they define electronic cigarettes as "tobacco products" under the Master Settlement Agreement (MSA) and thereby, they claim, make e-cigarettes subject to the advertising restrictions that the MSA poses on tobacco manufacturers.

The letter states: "we believe you could take a significant step in the battle against tobacco use by classifying e-cigarettes as cigarettes under the Master Settlement Agreement (MSA) with the tobacco companies. ... we are writing to urge you to consider using your authority under the MSA to take immediate actions against the efforts of e-cigarette companies to target youth."

The letter also states: "We believe e-cigarettes meet all the criteria for the definition of cigarette (and tobacco product) in the Master Settlement Agreement. .. They contain "tobacco, ... in any form" because their key ingredient is nicotine, which is produced from tobacco leaves."

The Rest of the Story

Stan Glantz has praised this action of these politicians. I, on the other hand, condemn it.

Why? Because, very simply, it is unconstitutional. It clearly violates the rights of electronic cigarette companies. Specifically, it makes the electronic cigarette companies parties to a contract that they didn't sign. The government cannot do that. No one can do that. A contract is an agreement that is approved by the participating parties. A contract between these parties cannot tell other parties what they may or may not do. The Master Settlement Agreement was signed by the Attorneys General and several participating manufacturers (mainly, the large tobacco companies). It cannot set rules for other companies that were not parties to the agreement.

Moreover, these politicians are completely misinterpreting the Master Settlement Agreement. They misinterpret the MSA in two ways.

First, e-cigarettes are clearly not "cigarettes" as defined by the MSA. In order to be classified as a cigarette under the MSA, a product must contain tobacco. However, e-cigarettes do not contain tobacco. The politicians try to get around this by arguing that because they contain nicotine, they contain tobacco, as nicotine is derived from tobacco. But this argument flies in the face of basic rules of statutory construction. If the intent of the MSA was to define all nicotine-containing products as tobacco products, then it would not have been necessary to include the additional clause specifying that tobacco products must not only contain nicotine, but also contain tobacco.

Second, even if the Attorneys General redefine electronic cigarettes as tobacco products, that does not make the e-cigarette companies subject to the marketing restrictions in the MSA. The marketing restrictions only apply to "participating manufacturers." Because e-cigarette companies are obviously not "participating manufacturers," they cannot be subject to the MSA's marketing restrictions, regardless of how "tobacco products" are defined.

The rest of the story is that e-cigarette opponents like Stan Glantz and these politicians are so zealous about demonizing electronic cigarettes that they are willing to violate constitutional principles and basic legal rights of companies in order to achieve their aims.

A national public opinion survey of 2,154 adult Canadians taken by the Forum Poll found that among smokers who used electronic cigarettes primarily as a smoking cessation tool, 24% had quit smoking.

The study concluded that: "many vapers are trying to quit smoking tobacco, and between a quarter and a third are successful at this. So, it appears e-cigarettes don't represent the trojan horse they are painted as, and may be a very useful smoking cessation aid."

The Rest of the Story

It seems fortunate that a large number of smokers in Canada have ignored Health Canada's advice not to use electronic cigarettes. The health agency had advised smokers "not to purchase or use electronic smoking products, as these products
may pose health risks and have not been fully evaluated for safety,
quality and efficacy by Health Canada." Had all smokers taken Health Canada's advice, it appears that as many as one quarter of them who otherwise would have quit would instead still be smoking. It is ironic and unfortunate that a national health agency put out advice which runs contrary to the best interests of the public's health.

Due to differences in the legal status of e-cigarettes in the U.S. and Canada, these results cannot be extrapolated to the U.S. In Canada, the sale of nicotine-containing e-liquids was banned, although use by individuals is still legal. Therefore, it is possible that smokers in Canada who use electronic cigarettes are particularly motivated to quit smoking. This could, in part, explain the high observed smoking cessation rate in the survey.

I doubt that anti-smoking advocates and groups who oppose e-cigarettes will pay any heed to the results of this survey, as they appear not to be concerned with the actual scientific evidence, but instead, appear to have already drawn their conclusions. Nevertheless, if enough evidence accumulates to show that e-cigarettes are helping many smokers to quit, eventually it will be impossible for public policy makers to deny that e-cigarettes are a bona fide smoking cessation tool, despite the propaganda being disseminated by the anti-smoking groups.

Of note, the survey found that among those who are unsuccessful in quitting using e-cigarettes, about half have reduced the amount that they smoke. Thus, e-cigarettes may be benefiting those who fail to quit by reducing the damage done to the lungs and by decreasing the level of their addiction to smoking.

Also of note, 70% of smokers surveyed who had used e-cigarettes to try to quit reported that these products were somewhat or very effective in helping them quit. Despite the pre-determined conclusions of many anti-smoking groups, consumers seem to be indicating that these products can work.

Although penetration of
e-cigarettes is not that high now, those using them are the young, and
this behaviour is bound to become more popular. It appears, contrary to
authorities' fears, that vaping is not a gateway to tobacco smoking, and
many people who never smoked enjoy e-cigs for the flavours, not the
nicotine. On the other hand, many vapers are trying to quit smoking
tobacco, and between a quarter and a third are successful at this. So,
it appears e-cigarettes don't represent the trojan horse they are
painted as, and may be a very useful smoking cessation aid

Although penetration of
e-cigarettes is not that high now, those using them are the young, and
this behaviour is bound to become more popular. It appears, contrary to
authorities' fears, that vaping is not a gateway to tobacco smoking, and
many people who never smoked enjoy e-cigs for the flavours, not the
nicotine. On the other hand, many vapers are trying to quit smoking
tobacco, and between a quarter and a third are successful at this. So,
it appears e-cigarettes don't represent the trojan horse they are
painted as, and may be a very useful smoking cessation aid

Although penetration of
e-cigarettes is not that high now, those using them are the young, and
this behaviour is bound to become more popular. It appears, contrary to
authorities' fears, that vaping is not a gateway to tobacco smoking, and
many people who never smoked enjoy e-cigs for the flavours, not the
nicotine. On the other hand, many vapers are trying to quit smoking
tobacco, and between a quarter and a third are successful at this. So,
it appears e-cigarettes don't represent the trojan horse they are
painted as, and may be a very useful smoking cessation aid

Friday, December 19, 2014

A new study published in the American Journal of Preventive Medicine refutes the claim that electronic cigarettes are a gateway to smoking.

(See: Meier EM, Tackett AP, Miller MB, Grant DM, Wagener TL. Which nicotine products are gateways to regular use? First-tried tobacco and current use in college students. American Journal of Preventive Medicine 2015; 48(S1):S86-S93.)
The paper reports the results of an online survey of 1,304 undergraduate students at a large university in Oklahoma. The mean age of respondents was 19.6 years. Students were asked to report:

(1) the first nicotine-containing product they used (cigarettes, smokeless tobacco, electronic cigarettes, hookah, or NRT); and

(2) all of the nicotine-containing products that they current use.

Thus, the study was able to ascertain the proportion of students who had initiated nicotine use with electronic cigarettes and went on to become smokers (and remained smokers at the time of the survey).

The two most important findings of the study were as follows:

(1) Of the 1,304 students, only 3 reported having first tried electronic cigarettes and currently being a smoker. There were 59 students who had initiated with electronic cigarettes, so the proportion of these students who progressed to smoking and were currently smoking was 5.1%. In contrast, 18.6% of students who initiated nicotine use with smokeless tobacco progressed to smoking and were currently smoking.

(2) Of the 59 students who initiated nicotine use with e-cigarettes, only 1 was currently using e-cigarettes, and this student reported only occasional use of these products.

The authors conclude that: "ETPs were the first product tried by some students (n=59), 78%
of whom first tried e-cigarettes. Interestingly, only one of these
students was still using an ETP at the time of the study, and this was
reported as occasional use of e-cigarettes. This may suggest that the
uptake potential of current ETPs is limited among youth. This finding is
supported by the fact that all dissolvable tobacco products have been
taken off of the market by tobacco companies owing to poor uptake of
these products.29
Moreover, given the timing of data collection, it is likely that
students who first tried e-cigarettes tried a first-generation device,
which anecdotally is considered to be much less effective in delivering
nicotine than newer models.30
In addition, only one student who initiated with an ETP (1.7%) was a
daily user of any tobacco product (i.e., conventional cigarettes),
compared to the 10% and 21% of current daily tobacco users who first
tried conventional cigarettes and SLT, respectively. Though this finding
should be interpreted with caution, it potentially indicates that
current ETPs are not necessarily strong gateways to regular tobacco use."

The Rest of the Story

This is the first study designed to actually answer the question of whether electronic cigarettes are a gateway to smoking because it is the first one to assess whether e-cigarette use preceded or followed cigarette use. It is inexplicable why some tobacco control advocates (Stan Glantz) and public health agencies (the CDC) had already concluded that e-cigarettes are a gateway to smoking in the absence of a single study that actually examined this question.

This study found only three students, in a sample of 1,300, who had initiated nicotine use with e-cigarettes and progressed to smoking. Moreover, only one of the students who initiated nicotine use with e-cigarettes was still using e-cigarettes, and only occasionally.

These findings refute the claim that electronic cigarettes are a gateway to smoking. Moreover, they suggest that the addictive potential of electronic cigarettes is quite low. The results support my contention that the public health consequences of e-cigarette experimentation among youth are not as dire as is being claimed by anti-smoking groups and health agencies. The current evidence does not support the conclusion that e-cigarette experimentation is a significant cause of nicotine addiction and subsequent uptake of smoking among youth.

There is one major caveat with this research. The sample consisted of college students and at the time many of them were in high school, e-cigarette use was not as popular. Also, most of these students probably initiated with first generation e-cigarette products, which do not deliver nicotine as effectively as more recently introduced products. Thus, to definitively answer the gateway question, we need a similar study among younger youth.

Despite this limitation, the rest of the story is that based on the current available evidence, there is no basis for concluding that e-cigarettes are a gateway to smoking. The CDC should immediately retract its claim that these products are a gateway to smoking to ensure that public policy is formulated based on science, rather than ideology.

The authors describe their study inclusion criteria as follows: "We included randomized controlled trials (RCTs) in which current smokers
(motivated or unmotivated to quit) were randomized to EC or a control
condition, and which measured abstinence rates or changes in cigarette
consumption at six months or longer. As the field of EC research is new,
we also included cohort follow-up studies with at least six months
follow-up. We included randomized cross-over trials and cohort follow-up
studies that included at least one week of EC use for assessment of
adverse events."

The results of the study were as follows: "Participants using an EC were more likely to have abstained from smoking
for at least six months compared with participants using placebo EC (RR
2.29, 95% CI 1.05 to 4.96; placebo 4% versus EC 9%; 2 studies; GRADE:
low). The one study that compared EC to nicotine patch found no
significant difference in six-month abstinence rates, but the confidence
intervals do not rule out a clinically important difference (RR 1.26,
95% CI: 0.68 to 2.34; GRADE: very low). A higher number of people were
able to reduce cigarette consumption by at least half with ECs compared
with placebo ECs (RR 1.31, 95% CI 1.02 to 1.68, 2 studies; placebo: 27%
versus EC: 36%; GRADE: low) and compared with patch (RR 1.41, 95% CI
1.20 to 1.67, 1 study; patch: 44% versus EC: 61%; GRADE: very low).
Unlike smoking cessation outcomes, reduction results were not
biochemically verified. None of the RCTs or cohort studies reported any serious adverse events
(SAEs) that were considered to be plausibly related to EC use."

The authors conclude: "There is evidence from two trials that ECs help smokers to stop smoking
long-term compared with placebo ECs. However, the small number of
trials, low event rates and wide confidence intervals around the
estimates mean that our confidence in the result is rated 'low' by GRADE
standards. The lack of difference between the effect of ECs compared
with nicotine patches found in one trial is uncertain for similar
reasons. ECs appear to help smokers unable to stop smoking altogether to
reduce their cigarette consumption when compared with placebo ECs and
nicotine patches, but the above limitations also affect certainty in
this finding. In addition, lack of biochemical assessment of the actual
reduction in smoke intake further limits this evidence. No evidence
emerged that short-term EC use is associated with health risk."

The Rest of the Story

There is clearly a need for further research in this area, and the authors make it clear that they have low confidence in their conclusions because of the limited evidence. However, it does appear that at the current time, there is evidence that electronic cigarettes can be useful for smoking cessation and reduction and that they are probably at least as effective as other FDA-approved therapies. In addition, there is no evidence that these products cause any serious adverse side effects, at least in terms of short-term use.

These conclusions refute the statements being made by a number of tobacco control researchers and advocates that electronic cigarettes actually inhibit smoking cessation. And they also refute statements by some health agencies that there is no evidence that electronic cigarettes have any usefulness for smoking cessation.

There is an urgent need for a high-quality clinical trial of electronic cigarettes in the United States, especially since more conclusive information is necessary to inform the FDA as it prepares and implements regulations. I developed a protocol for such a study, but was unable to secure funding from electronic cigarette companies to conduct the study. Hopefully, someone will be able to secure funding. I am happy to share my protocol with any researchers who are interested in potentially conducting such a study.

Wednesday, December 17, 2014

In response to the release of the 2014 Monitoring the Future data, which show that more youth are experimenting with electronic cigarettes than smoking (in terms of past 30-day use), many anti-smoking groups have sounded the alarm. More specifically, these groups have told the public that these data demonstrate that e-cigarettes are normalizing smoking. As Sabrina Tavernese explains in her New York Timesarticle: "Health advocates say the trend for e-cigarette use is dangerous because it is making smoking seem normal again." For example, the American Academy of Family Physicians argued that these data show that e-cigarette use is normalizing smoking.

I have already explained how anti-smoking groups are missing the most important finding from the Monitoring the Future study: that despite the dramatic increase in e-cigarette experimentation, youth smoking prevalence declined substantially and is at its lowest level in decades. This demonstrates that e-cigarettes are not a gateway to smoking, as has been claimed by the CDC and by some tobacco control advocates, led by Stan Glantz.

Thus, it turns out that the concern of anti-smoking groups that e-cigarettes will normalize smoking is misplaced. In fact, the evidence seems to suggest just the opposite. It may well be that e-cigarettes are de-normalizing smoking by actually diverting some youth who would otherwise have smoked to e-cigarettes, or by diverting some youth smokers to vaping. What e-cigarette use is normalizing is the use of electronic cigarettes, not the use of tobacco cigarettes. The anti-smoking groups fail to see this because they have drawn pre-determined conclusions based on their ideology, and they are not able to look objectively at the actual scientific evidence.

While the health groups got the story wrong, fortunately, Sabrina Tavernese got it right: "Health advocates say the trend for e-cigarette use is dangerous because
it is making smoking seem normal again. They also worry it could lead to
an increase in tobacco smoking, though the new data do not show that."

Today, I reveal another important finding of the recent surveys on electronic cigarette use that has been entirely ignored and which should lessen our concern about the public health implications of e-cigarette experimentation among youth.

The Rest of the Story

Another important finding of the recent surveys, which has been completely ignored, is the finding that despite the large number of youth who are experimenting with e-cigarettes, only a very small proportion are actually using these products regularly, in a way that could plausibly cause significant harm. Wills et al. found that although 29% of high school students had experimented with e-cigarettes, only 2% were using them more than once a week. This means that only 7% of all high school e-cigarette experimenters are vaping more than once a week, which should lessen concerns that these products are causing significant health harm.

The truth is that e-cigarettes pose little acute health harm. Almost all the potentially adverse health effects of e-cigarette use are related to long-term use (over a period of many years). The potential acute health effects are basically two-fold: (1) these products could potentially be a gateway to smoking; and (2) these products could addict kids to nicotine, causing prolonged use of e-cigarettes which could cause neurological damage.

As I discussed above, concern #1 does not appear to be a problem. And based on the Wills et al. data, it does not appear that #2 is currently a major problem either. The data suggests that despite the dramatic rise in e-cigarette experimentation, youth are not becoming addicted to these products. The pattern of e-cigarette use is almost entirely sporadic, with 93% of users vaping no more than once in an entire week. It is not clear that use of e-cigarettes at this level - only once a week - poses any significant health harms.

My point is that the public health significance of youth e-cigarette use may very well be positive, rather than negative. It is possible that these products have caused very little health harm, while at the same time, diverted many youth from smoking to vaping. We know that smoking experimentation quickly leads to addiction. But e-cigarette use does not appear to have the same level of addictiveness. Possibly because of the much lower and inconsistent nicotine delivery, these products do not appear to be creating e-cigarette addicts (among youth).

If it is true that e-cigarettes are diverting some youth away from smoking, then it is actually the case that e-cigarette use among youth is having a positive net effect on the public's health. Even if this is not the case, it appears that e-cigarette use among youth is having very little public health impact, thus meaning that the benefits of e-cigarettes for adults (smoking reduction and cessation) far outweigh the costs for youth.

Let me close by making one point very clear. I am not arguing that e-cigarette use among youth is not a concern, that youth e-cigarette use should be allowed or promoted, or that measures should not be taken to discourage e-cigarette use among youth. I support bans on the sale of e-cigarettes to minors, restrictions on advertising and marketing that is directed at youth, programs to educate youth about e-cigarettes, programs to discourage kids from using e-cigarettes, and most importantly, FDA regulations that require child-proof packaging on e-cigarettes and stronger warnings about the potential risks of nicotine (especially acute poisoning).

Nevertheless, it is critical that we get the science right. And as of today, the science suggests that: (1) e-cigarettes are not a gateway to smoking among youth; and (2) e-cigarettes may well be de-normalizing smoking rather than promoting it.

Tuesday, December 16, 2014

In an article published yesterday in USA Today, Dr. Stanton Glantz states definitively that electronic cigarettes are a gateway to smoking. He was quoted as stating: "There's no question that e-cigarettes are a gateway to smoking."

The article highlights the findings of two new studies showing that rates of electronic cigarette use among youth continue to rise dramatically. According to the article: "About 25% of high school students in Connecticut and 29% of teens in
Hawaii have used e-cigarettes, according to separate studies. About 18%
of the Hawaii teens and 12% of the Connecticut high school students had
used e-cigarettes in the past month. Both studies were done in 2013. Those
rates are much higher than the latest data from the Centers for Disease
Control and Prevention, which found 4.5% of high schoolers and 1.1% of
middle schoolers had used e-cigarettes in the past 30 days in 2013. Authors of the Hawaii study, published online Monday in Pediatrics, note that e-cigarette use has grown exponentially among kids, doubling every year since 2009."

Today, the University of Michigan released data from the 2014 Monitoring the Future study which confirm that among a national sample of 8th, 10th, and 12th grade youth, rates of electronic cigarette use are between 9% and 17%. The prevalence of past 30-day use of electronic cigarettes was 8.7% among 8th graders, 16.2% among 10th graders, and 17.1% among 12th graders.

The Monitoring the Future study also found that the prevalence of cigarette smoking decreased substantially in all three groups. For 8th graders, the prevalence of past 30-day smoking dropped from 4.5% to 4.0%; for 10th graders, current smoking prevalence dropped from 9.1% to 7.2%, and among 12th graders, smoking prevalence dropped from 16.3% to 13.6%. In 2014, cigarette smoking was at its lowest level in decades.

The most dramatic declines in smoking occurred between 2011 and 2014. For 8th graders, smoking prevalence dropped from 6.1% to 4.0%; among 10th graders, smoking prevalence dropped from 11.8% to 7.2%; and among 12th graders, smoking prevalence dropped from 18.7% to 13.6%. However, the decline in smoking from 2013 to 2014 was by far the most substantial year-to-year decrease during this period.

The Rest of the Story

It is clear that experimentation with electronic cigarettes among youth has increased dramatically from 2011 to 2014. But despite this dramatic increase, the prevalence of current smoking among youth decreased dramatically. And the sharpest decline in smoking occurred concurrently with the largest increase in electronic cigarette use.

Dr. Glantz's conclusion - that electronic cigarettes are a gateway to smoking - just doesn't hold up in light of these data. If electronic cigarettes were serving as a major gateway to smoking, then we wouldn't expect to see such dramatic declines in smoking concurrent with dramatic increases in electronic cigarette experimentation. If anything, these national data suggest that electronic cigarettes may actually be serving as a deterrent to smoking by diverting kids who might otherwise try smoking over to a non-tobacco nicotine product. Even if it is the case that kids who might not have tried smoking are experimenting with e-cigarettes, this is very different from claiming that e-cigarettes are a gateway to smoking.

Furthermore, there simply are no studies to support the conclusion that e-cigarettes are a gateway to smoking. The only existing evidence suggests that e-cigarettes are not serving as a major gateway to smoking. Thus, Glantz has drawn a conclusion that is simply unsupported by any evidence.

Glantz now joins the CDC in disseminating the unsupported conclusion that e-cigarette experimentation is a gateway to smoking. One unfortunate consequence of public health agencies or researchers spreading this misinformation is that we risk losing our credibility, not just on the issue of electronic cigarettes, but on other issues as well. If we are not credible with respect to our opinions on electronic cigarettes, then why should the public trust us when we comment about tobacco cigarettes?

Sadly, this story simply adds to the long list of examples of the degradation in the rigor of science in the tobacco control movement.

Sunday, December 14, 2014

For the past two years, the Centers for Disease Control and Prevention (CDC) has been on a crusade to demonize electronic cigarettes. The agency has falsely claimed that its survey data demonstrate that electronic cigarettes are a gateway to cigarette smoking among youth. The agency has fabricated evidence that ex-smokers are in large numbers being driven back to smoking because of electronic cigarettes. The agency has scared the public by noting that rates of experimentation with electronic cigarettes doubled among youth, but failed to mention that almost all regular e-cigarette users were smokers or users of other forms of tobacco.

Now, the CDC is trying to dissuade the public from believing that vaping is safer than smoking. However, the worst thing the agency is able to say about the hazards of electronic cigarettes is that they are not as safe as "clean air."

In a December 12 MMWRarticle on electronic cigarettes, the CDC writes that some "contend that ENDS [electronic cigarettes] emit fewer toxins than combustible tobacco... . However, ENDS aerosol is not as safe as clean air."

The Rest of the Story

There are two striking things about these CDC statements.

First, it is extremely misleading to write that some groups "contend" that electronic cigarettes emit fewer toxins than combustible tobacco. By framing it in this way, the CDC is giving the impression that it does not agree with this contention, or at least, that the evidence is not clear.

However, there is abundant evidence that what these groups "contend" is the documented scientific truth. There is abudant evidence that electronic cigarettes emit fewer toxins than combustible tobacco, and no reputable scientist would argue otherwise. But by framing this as merely a contention, the CDC is insinuating that we don't actually know that electronic cigarettes emit fewer toxins.

Why would the CDC want to suggest to the public that we don't actually know that electronic cigarettes deliver fewer toxins that tobacco cigarettes? To me, this indicates a desire to demonize these products. Otherwise, why should the CDC be scared to tell the public the truth: that electronic cigarettes are much safer than tobacco cigarettes? And this isn't even going that far. It's merely acknowledging that e-cigarettes deliver fewer toxins than tobacco cigarettes.

Frankly, the CDC is using what we previously would have referred to as "tobacco speak." This is the way that the tobacco companies historically would frame their statements about the health effects of smoking. They would say things like: "Some public health officials contend that smoking causes ... ." Why is CDC now stooping to this level?

The second striking thing about the statement is that apparently, the worst thing the CDC can say about the adverse health effects of electronic cigarettes is that these products are not as safe as inhaling "clean air."

If that's the worst thing the CDC can say, then electronic cigarettes are apparently not that hazardous, or at least there is not currently any evidence to support the contention that they pose major hazards. Besides, you could say the same thing about any airborne exposure, including exposure to FDA-approved products. For example, you could correctly state that "aerosol from nicotine inhalers is not as safe as clean air."

Actually, it depends on how you define clean air. If you define it as simply being outdoor air, then it may not even be true that electronic cigarette aerosol is not as safe as "clean air." After all, in many urban areas, there are high levels of pollution in outdoor air. This air pollution has been associated with adverse cardiac and respiratory effects. So it is entirely possible that for some urban dwellers, their "clear air" is actually more hazardous than inhaling e-cigarette aerosol.

The rest of the story is that the CDC continues to misrepresent scientific evidence in order to demonize electronic cigarettes. If you didn't know any better, you might think that the agency has been paid by Big Tobacco to undermine the public's appreciation of the severe hazards associated with cigarette smoking and that it is trying to preserve, rather than decimate, the combustible tobacco market.

Disclosure: I have not received any funding or compensation from
the tobacco, electronic cigarette, or pharmaceutical industries.
However, I am seeking funding from several electronic cigarette
companies to conduct a behavioral study on the effects of electronic
cigarettes on smoking behavior.

Thursday, December 11, 2014

A meta-analysis of the existing studies which examined the effectiveness of electronic cigarettes for smoking cessation has concluded that these products are indeed effective. The study abstract, which was published on the Circulation website, was presented at an American Heart Association conference.

The study concluded as follows: "Six studies were selected, including two randomised
controlled trials, two cohort studies and two cross-sectional studies,
and included 7,551 participants. Meta-analyses
included 1,242 participants on whom complete smoking cessation data was
available.
Of these, 224 (18%) reported smoking cessation
after using nicotine-enriched e-cigarettes for a minimum period of six
months.
Use of such e-cigarettes was positively
associated with smoking cessation with a pooled Effect Size of 0.20
(95% CI 0.11-0.28).
Nicotine filled e-cigarettes were more effective
in achieving cessation compared to
those without nicotine (pooled Risk Ratio 2.29, 95% CI 1.05-4.97). Use of e-cigarettes was also effective in reducing smokers’
daily cigarette consumption."

The Rest of the Story

This meta-analysis reports, as its primary outcome variable, the proportion of smokers using e-cigarettes who quit successfully at six months (or longer). The authors found that 18% of all the smokers using e-cigarettes in the combined studies had quit after six months. This provides preliminary evidence that e-cigarettes do appear to be modestly effective for smoking cessation and that they certainly compare equally or favorably to existing FDA-approved drugs.

In contrast, a previously published meta-analysis of the effectiveness of FDA-approved smoking cessation drugs focuses on the pooled odds ratios. In fact, the study does not even report the absolute cessation rates. Thus, the fact that the study was funded by Pfizer unfortunately appears to be creating a bias in result reporting, as the authors are hiding the key piece of information that readers need to understand whether these drugs are really effective, or whether they are just better than placebo, which has a dismal cessation rate. (None of the authors of the e-cigarette meta-analysis reported any conflicts of interest.)

Remember that a drug can produce an odds ratio of 2, yet represent an 8% cessation rate compared to a 4% cessation rate. Moreover, in these clinical trials, the subjects who received placebo were likely to have known that their medication was inactive and may have suffered a huge initial disappointment which would have resulted in very dismal success rates.

Because this is just an abstract and has not yet been peer-reviewed, its results should be viewed as preliminary. Nevertheless, the conclusion of the study casts doubt on the many anti-smoking groups and advocates who continue to argue that there is no evidence that electronic cigarettes have efficacy in smoking cessation.

Disclosure: I have not received any funding or compensation from
the tobacco, electronic cigarette, or pharmaceutical industries.
However, I am seeking funding from several electronic cigarette
companies to conduct a behavioral study on the effects of electronic
cigarettes on smoking behavior.

Sunday, December 07, 2014

Everyone involved in the debate over electronic cigarettes must read Dr. Michael Marlow's commentary on the FDA's proposed deeming regulations. According to his Mercatus Center biography, Dr. Marlow is "an affiliated senior scholar at the Mercatus Center at George Mason
University and professor of economics and distinguished scholar at
California Polytechnic State University, San Luis Obispo."

In his commentary, Dr. Marlow argues that in its proposed deeming regulations, the FDA has completely skewed its cost-benefit analysis by failing to recognize the dramatic negative effect its burdensome regulatory requirements for electronic cigarettes will have on the public's health by virtue of the suppression of the e-cigarette market that these regulations will cause.

Dr. Marlow writes:
"This article argues that the FDA
jeopardizes public health
by not developing an appropriate benefit-cost analysis of the
proposed rule. The FDA
“anticipates,” without quantifying, substantial benefits from reducing harm by regulating e-cigarettes
and non-cigarette tobacco products. The FDA
also does not adequately assess costs that appear likely from its suppression of the
e-cigarette market. The evolving literature on e-cigarettes strongly
suggests they help smokers to quit smoking. The proposed rule
endangers public health by pushing e-cigarette manufacturers to
focus efforts toward developing attributes unrelated to improved
public health, thereby promoting combustible tobacco use and
reducing the number of smokers who would use e-cigarettes to
quit or reduce cigarette consumption. Public health would worsen because e-cigarettes are a safer alternative to tobacco cigarettes."

Dr. Marlow carefully articulates the adverse consequences to the public's health that would occur if the FDA's proposed deeming regulations are adopted. These regulations, he argues, would result in the suppression of the e-cigarette market, a stifling of product innovation, a contraction of the overall e-cigarette market with limitation of consumer choices and increased product costs, and an increase in youth e-cigarette use due to the prohibition of honest claims that e-cigarettes are safer than combustible tobacco products.

Dr. Marlow concludes that: "The FDA needs to develop a regulatory strategy that fully considers the potential benefits that smokers receive from e-cigarettes and the many unintended adverse effects on public health associated with how this proposed regulation slows the evolution of a promising harm reduction tool."

The Rest of the Story

This commentary very nicely summarizes many of the major points that I have tried to make here at the Rest of the Story over the past months. Like Dr. Marlow, I have argued that the proposed deeming regulations would suppress the e-cigarette market, stifle innovation, and contract the overall market by reducing the number of players as well as consumer choices. The burdensome requirement for a new product application for virtually every e-cigarette product on the market will almost certainly drive most e-cigarette companies and shops out of business. The net effect of this disruption of the industry will be a reduction in the rate at which smokers switch from combustible cigarettes to the much safer electronic ones. Thus, the net effect of the proposed regulations would be a strongly negative impact on public health.

In addition, Dr. Marlow nicely articulates the argument I have previously made that by disallowing companies from truthfully informing their customers that these products are safer than tobacco cigarettes and may be helpful in smoking cessation, the result will be that companies have no option other than marketing these products as having benefits unrelated to health, such as looking cool and sexy and allowing smokers to inhale nicotine in places where smoking is not allowed. The net effect of this suppression of the truth will be an increase in youth e-cigarette use, as honest marketing of e-cigarettes based on their health benefits would have far less appeal to youth.

Instead of the burdensome requirements that the FDA is proposing, I believe that the agency should take a different approach which recognizes the vast difference in risk between tobacco and electronic cigarettes, which embraces the harm reduction potential of e-cigarettes, and which enhances the progression of the nicotine market away from combustible products.

Specifically, the FDA should:

Scrap the requirement that e-cigarette products must submit new product applications.

voltage and/or temperature regulation to avoid the formation of carbonyl compounds like formaldehyde;

manufacturing standards such as those set out by AEMSA;

banning the use of diacetyl as a flavoring; and

soldering restrictions to prevent the presence of metals in e-liquid.

4. Explicitly allow companies to truthfully inform their customers that these products are intended to aid in smoking cessation and that these products are much safer than tobacco cigarettes.
The last thing we need is the creation of a monstrous bureaucracy in which the FDA will have to review literally thousands of new product applications, including hundreds of applications - in some cases - from a single company. The FDA has not demonstrated how such a process, which is unduly burdensome, which actually benefit the public's health. Instead, the agency should simply mandate the safety standards that all companies must follow. This minimizes the bureuacracy, limits the economic and time burden on small companies, allows the market to continue to expand rather than contract, encourages innovation, and directly regulates the factors that will most affect product safety.

Disclosure: I have not received any funding or compensation from
the tobacco, electronic cigarette, or pharmaceutical industries.
However, I am seeking funding from several electronic cigarette
companies to conduct a behavioral study on the effects of electronic
cigarettes on smoking behavior.

Wednesday, December 03, 2014

New data reported by Clive Bates and presented in Joe Nocera's New York Timescolumn about electronic cigarettes reveal that there has been a major change in the public's appreciation of the severe hazards of smoking in the past three years:

According to these sources, in 2010, 80% of the public believed that smoking was more hazardous than using non-tobacco-containing, non-combustible electronic cigarettes.

However, in 2013, only 60% of the public believed that smoking was more hazardous than using non-tobacco-containing, non-combustible electronic cigarettes.

This is bad news for public health, as it indicates that within three years, the public's appreciation of the severe hazards of smoking has been undermined. Twenty percent of the public has been convinced that smoking is no more hazardous than inhaling aerosol from a device which involves no combustion and contains no tobacco.

The Rest of the Story

Who is responsible for this undermining of the public's appreciation of the health hazards of smoking?

Historically, it was the tobacco industry which used public relations activities to undermine the public's appreciation of smoking's health hazards.

Sadly, it was not the tobacco industry which is responsible for today's bad news. Instead, I believe that it is clearly the result of a strong propaganda campaign by the anti-smoking groups.

For the past three years, the mainstream anti-smoking groups, as well as federal agencies including the FDA and the CDC, have been disseminating the message that electronic cigarette use is harmful and they have largely hidden from the public the fact that vaping is much safer than smoking. In addition, a number of anti-smoking groups and advocates have actually been spreading misinformation about the health hazards of vaping and the relative hazards of smoking compared to vaping.

As a result of these information campaigns, it is now clear that the public's appreciation of the health hazards of smoking has been undermined, as there has been a substantial decline in the proportion of the public which correctly believes that smoking is more hazardous than vaping.

This is not just a friendly debate about the potential role of electronic cigarettes as a tobacco control strategy. This is now a situation where the mainstream anti-smoking groups are actually doing tangible and demonstrable public health harm by completely distorting the relative risks of smoking compared to vaping and as a result, undermining the public's appreciation of the hazards of smoking.

Disclosure: I have not received any funding or compensation from
the tobacco, electronic cigarette, or pharmaceutical industries.
However, I am seeking funding from several electronic cigarette
companies to conduct a behavioral study on the effects of electronic
cigarettes on smoking behavior.

Tuesday, December 02, 2014

Speaker of the House John Boehner, along with the House Majority Leader Kevin McCarthy and Chair of the Energy and Commerce Committee Fred Upton, have sent a letter to the FDA and Center for Tobacco Products urging that the proposed deeming regulations be changed. Specifically, they have requested that the FDA change the grandfather date of February 15, 2007 to either April 25, 2014 (the date the deeming regulation was published) or to the effective date of the final deeming regulation.

The representatives' concern is that with the proposed grandfather date, it will be virtually impossible for current electronic cigarette products to claim substantial equivalence to a predicate product. Therefore, virtually every electronic cigarette company will need to file a new product application, which is a burdensome and expensive undertaking. The net result could be the removal of thousands of electronic cigarette products from the market.

The letter asks the FDA to change the grandfather date "to ensure that these innovative
products are not snuffed out by overly burdensome regulations."

According to the letter: "As a practical matter, many newly
deemed products could be removed from the market. ... [T]he cost and barriers
surrounding a new product submission would largely prevent new entries, posing
an unwarranted regulatory barrier to innovation. ... This is a critical issue, and we request
that manufacturers of newly deemed tobacco products have the same market entry
opportunities as manufacturers of cigarettes and other currently regulated
tobacco products. ... Any final provision on this issue should ensure equity
among all regulated tobacco products and encourage innovation while achieving
the purpose of the law."

The Rest of the Story

I agree with the request that is being made in this letter. However, I would go further and recommend that the FDA not require new product applications for any products. Doing so stifles innovation and makes it difficult if not impossible for newer products that may be safer and more effective to enter the market.

These comments are similar to those expressed by Altria Client Services, Lorillard, and the American E-Liquid Manufacturing Standards Association.

They also echo my initial comments about the proposed deeming regulations, when I wrote:

"This provision is going to present a huge obstacle to innovation in this
category. The newer products tend to be safer and more effective, so it
makes no sense to allow the older products to remain on the market
while requiring pre-approval for the newer and better products. The
implications of this regulation is going to depend on the evidence that
the agency requires to approve these applications. A stringent
interpretation of the regulations will put a huge dent in electronic
cigarette innovation and could limit the expansion of the market. In
addition, this provision is going to place an undue burden on smaller
companies and give a huge advantage to larger companies, including the
tobacco companies that have entered the e-cigarette market."

"The regulations require pre-approval
or substantial equivalence determinations of almost all existing
electronic cigarette products."

"This provision is going to wreak havoc with the industry. The agency is
determined that it cannot extend the grandfather date beyond 2007. This
means that any product not on the market as of 2007 (which includes
almost all electronic cigarette products) must either obtain a new
product approval or a substantial equivalence determination. Given the
snail's pace at which the FDA has processed cigarette substantial
equivalence determinations, this could result in a literal quagmire of
pending applications for the more than 250 brands of e-cigarettes
currently on the market."

(Thanks to Greg Conley for the tip.)

Disclosure: I have not received any funding or compensation from
the tobacco, electronic cigarette, or pharmaceutical industries.
However, I am seeking funding from several electronic cigarette
companies to conduct a behavioral study on the effects of electronic
cigarettes on smoking behavior.

Monday, December 01, 2014

The Boulder (Colorado) City Council is considering legislation that would extend the city's smoking ban to include parks and open spaces and ban vaping in all the places where smoking is banned. Thus, the ordinance would ban vaping in all parks and open spaces. Specifically, vaping would be banned in the following outdoor areas:

the downtown business improvement district;

all parks and parkland;

all open spaces and mountain parks property; and

on any trail or multi-use path.

What is the city's justification for considering a ban on vaping in these wide-open outdoor areas? What is the evidence the city presents to justify such a draconian measure?

If you read the city's fact sheet on electronic cigarettes, you'll find out that the city does not name a single health problem that has been shown to be caused by exposure to "secondhand vapor." Instead, the worst thing that the city health department can say about secondhand vaping is this:

"ENDS [electronic cigarettes] aerosol has consistently been demonstrated to contain more than water."

The Rest of the Story

When the worst thing that can be said about the potential public health hazard of exposure to exhaled e-cigarette aerosol is that the aerosol has been shown to contain more than water, you know that you are dealing with a flimsy justification for this proposed policy.

This is truly a draconian policy. There is no scientific justification for banning smoking in wide-open outdoor spaces; there is absolutely no scientific justification for banning vaping in these places. It isn't even clear whether vaping indoors poses any significant hazards to the public. Certainly, vaping outdoors poses no substantial public health risks.

Beyond the lack of any public health justification for this vaping ban, the policy is flawed because it would likely discourage many smokers from quitting smoking via electronic cigarettes. It might even encourage some vapers to return to cigarette smoking. It is possible, then, that this policy could have negative net public health benefits.

Hopefully, the Boulder City Council will choose not to include vaping in this expanded smoking ordinance.

Disclosure: I have not received any funding or compensation from
the tobacco, electronic cigarette, or pharmaceutical industries.
However, I am seeking funding from several electronic cigarette
companies to conduct a behavioral study on the effects of electronic
cigarettes on smoking behavior.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.